Surgical stapler and method

ABSTRACT

The present disclosure relates to surgical instruments including a staple anvil formed in a distal end of the surgical stapler and a staple cartridge selectively receivable in a distal end of the surgical stapler and in juxtaposition relative to the staple anvil, the staple cartridge including one or more laterally spaced apart rows of staple slots formed in an upper surface thereof, a plurality of surgical staples disposed, one each, within the staple slots, and a staple line reinforcing system configured and adapted to augment the strength of the staple line formed by the firing of the surgical staples into body tissue, wherein the surgical stapler concomitantly drives the plurality of surgical staples through the adjacent layers of body tissue to mechanically secure the body tissue and activates the reinforcing system to non-mechanically secure the adjacent layers of body tissue to one another.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.10/510,451 filed Oct. 4, 2004 now U.S. Pat. No. 7,517,356,which is a 371of application No. PCT/US03/11778 filed Apr. 16, 2003, which claimsbenefit of application No. 60/373,224 filed Apr. 16, 2002, and thedisclosures of each of the above-identified applications are herebyincorporated by reference in their entirety.

BACKGROUND

1. Technical Field

The present disclosure relates to surgical instruments and methods forenhancing properties of tissue repaired or joined by surgical staplesand, more particularly to surgical instruments configured to applysurgical mechanical fasteners concomitantly with a non-mechanicalbiocompatible wound closure material to enhance the properties ofrepaired or adjoined tissue at a target surgical site.

2. Discussion of Related Art

Throughout the years the medical field has utilized various techniquesin an effort to join or bond body tissue together. Historically,suturing was the accepted technique for rejoining severed tissues andclosing wounds. Suturing was historically achieved with a surgicalneedle and a suturing thread, and more recently, with a variety ofpolymeric or metallic staples, as will be discussed below. The intendedfunction of sutures is to hold the edges of a wound or tissue againstone another during the healing process so as to reduce discomfort, pain,scarring and the time required for healing.

Recently, many procedures which in the past required conventionalsuturing have been replaced by staple suturing which involves theapplication of the staples to the edges of the wound or tissue with theuse of a surgical stapler. Surgical staplers have been developed forjoining adjacent tissue, for providing hemostasis of adjacent tissue andfor providing hemostasis in conjunction with cutting of adjacent tissue.Such surgical staplers include both linear and annular typeconfigurations. A typical linear stapler and cutter includes parallelrows of staples with a slot for a cutting means to travel between therows of staples. Typical linear type staplers are disclosed in commonlyassigned U.S. Pat. No. 6,045,560 to McKean et al., U.S. Pat. No.6,032,849 to Mastri et al., and U.S. Pat. No. 5,964,394 to Robertson,the entire contents of each of which are incorporated herein byreference. A typical annular stapler and cutter, including a pluralityof annular rows of staples, typically two, and an annular blade disposedinternal of the rows of staples, is disclosed in commonly assigned U.S.Pat. Nos. 5,799,857 and 5,915,616 to Robertson et al., the entirecontents of each of which are incorporated herein by reference. Thesetypes of surgical staplers secure adjoining body tissue for improvedcutting, join layers of tissue to one another and provide hemostasis byapplying parallel or annular rows of staples to surrounding tissue asthe cutting means cuts between the parallel or annular rows.Accordingly, by enabling a surgeon to perform all of these taskssimultaneously, surgical staplers have been effective in decreasing theamount of time it takes to fasten tissue together. To even furtherenhance joining and hemostasis in instances where the stapler is used inhighly vascularized tissue, surgical staplers with multiple rows ofstaples have been used with a high degree of success.

Another procedure which has been developed includes the use of energyfor welding or otherwise joining or connecting biological tissue. Forexample, RF (radio-frequency) energy has recently been utilized in bothuni- and bi-polar generators to attempt to “weld” or “solder” biologicaltissue. Uni-polar devices utilize one electrode associated with acutting or cauterizing instrument and a remote return electrode, usuallyadhered externally to the patient. Bi-polar devices involve the use ofan instrument having two electrodes wherein the cauterizing current isgenerally limited to tissue solely between two electrodes of theinstrument.

Use of energy to effect wound closure or other reconstruction ofbiological tissue involves the application of energy to produce thermalheating of the biological tissue to degrees suitable for denaturing thetissue proteins such that the collagenous elements of the tissueform“biological glue” which seals the tissue to effect the joining. Thisglue is later reabsorbed by the body during the healing process.

In addition, biological tissue adhesives have recently been developedfor tissue repair and the creation of anastomoses. Generally, biologicaladhesives bond separated tissues together to aid in the healing processand to enhance the tissue strength. Such adhesives may be used insteadof suturing and stapling for example in surgical procedures for therepair of tissue or the creation of anastomoses.

The application of a suitable biocompatible adhesive offers manyadvantages to the patient and the surgeon alike such as, for example,the avoidance of penetration of tissue by needles and/or staples, aswell as the immediate sealing of the tissue being treated. Moreover, useof a biocompatible adhesive tends to minimize foreign body reaction andscarring. Despite these advantages, however, the weakness along thetissue seam remains as a primary disadvantage in the use ofbiocompatible adhesives.

Therefore, there is a need for surgical stapler instruments, for examplesurgical fasteners or staplers which reduce the trauma suffered by apatient, reduce the number of gaps between or at individual staplesites, reduce leakage of fluids, reduce bleeding, and/or which create arelatively strong bond between adjacent body tissues, e.g., along staplelines and tissue seams.

SUMMARY

The present disclosure relates to surgical instruments and methods forenhancing the properties of tissue to be repaired or joined.

According to one aspect of the present disclosure a method for enhancingone or more properties of body tissue to be repaired or joined bysurgical staples includes the step of providing a surgical staplerincluding a staple anvil and a staple cartridge each positioned adjacenta distal end of the surgical stapler and operable in juxtapositionrelative to each other. The staple cartridge includes a working surface,one or more rows of individual staple slots formed in the workingsurface, a plurality of surgical staples individually disposed withinthe individual staple slots, a driving member for firing the surgicalstaples from their slots and against the staple anvil, a body tissueproperty enhancing system configured and adapted to enhance one or moreproperties of the body tissue to be repaired or joined by the surgicalstaples formed by firing them into body tissue, the body tissue propertyenhancing system including a reservoir of biocompatible wound closurematerial and a plurality of ducts in communication with the reservoirand the working surface of the cartridge, and a plurality of deployableneedles each having a tip, the needles being adapted and disposed in theducts such that the tips can be extended out of the working surface ofthe staple cartridge to penetrate at least a layer of adjacent layers ofbody tissue and to allow the biocompatible wound closure material to bedelivered along the exterior of the needles to penetrate one or morelayers of body tissue.

The method further includes the steps approximating the staple anvil andstaple cartridge with adjacent layers of body tissue therebetween, andfiring the surgical stapler, wherein firing of the surgical staplerincludes driving the plurality of surgical staples through the adjacentlayers of body tissue to mechanically secure the layers of body tissuetogether and concomitantly activating the body tissue enhancing systemto enhance one or more properties of the adjacent layers of repaired orjoined body tissue.

It is envisioned that the activating of the body tissue propertyenhancing system includes delivering an amount of the biocompatiblewound closure material to at least one of or between the adjacent layersof repaired or joined body tissue. Upon firing of the surgical stapler,the biocompatible wound closure material is expelled from the reservoirof the staple cartridge.

It is further envisioned that in the providing step each of theplurality of deployable needles is normally biased to a non-extendedposition and is movable against the bias to the extended position.

The activating of the body tissue property enhancing system includesdelivering an amount of energy to at least one of or between theadjacent layers of body tissue to cauterize at least one of or theadjacent layers of body tissue.

The plurality of deployable needles are adapted to deliver the amount ofenergy to at least a layer of the body tissue to cauterize the bodytissue.

The biocompatible wound closure material is an adhesive material. It iscontemplated that the adhesive material is made of a protein derived,aldehyde based adhesive material. Alternatively, it is contemplated thatthe adhesive material is made of an albumin/glutaraldehyde material. Theadhesive material can be a cyanoacrylate-based material.

It is envisioned that the biocompatible wound closure material is atissue sealant material, wherein the tissue sealant material is made ofa synthetic polyethylene glycol-based hydrogel material.

It is further envisioned that the biocompatible wound closure materialis a hemostat, wherein the hemostat is made of a combination offibrinogen and thrombin.

According to another aspect of the present disclosure, a surgicalstapler is provided and includes a first jaw adapted to receive a staplecartridge in a distal end of the first jaw, the staple cartridgecontaining a plurality of individual surgical staples, and having aworking surface with a plurality of staple slots formed therein, asecond jaw having a staple anvil in a distal end of the second jaw, suchthat during the operation of the surgical stapler the staple cartridgeand the staple anvil can be approximated relative to one another, adriving member for firing the surgical staples from their staple slotsand against the approximated staple anvil, and a body tissue propertyenhancing system for enhancing one or more properties of body tissue tobe repaired or joined by the surgical stapler. The body tissue propertyenhancing system includes a biocompatible wound closure materialdispensing system for dispensing an amount of surgically biocompatiblewound closure material to a target staple site during at least one ofprior to, after and concomitant with a firing of the surgical stapler toexpel the plurality of staples loaded in the staple cartridge, the bodytissue property enhancing system comprising at least one reservoirdisposed in the staple cartridge for containing the biocompatible woundclosure material therein, a plurality of ducts formed in the staplecartridge, wherein the plurality of ducts communicate with and extendfrom the at least one adhesive reservoir to the working surface of thestaple cartridge, and a plurality of deployable needles each having atip, the needles being adapted and disposed in the ducts of the staplecartridge such that their tips can be extended out of the workingsurface of the staple cartridge to penetrate at least a layer of theadjacent layers of body tissue and to allow the biocompatible woundclosure material to be delivered along the exterior of the needles topenetrate one or more layers of the body tissue.

The first jaw is adapted to receive a drive member adapted to beslidingly disposed within the staple cartridge, the drive member beingadapted to force the biocompatible wound closure material from thereservoir out through the plurality of ducts and about the needlesdisposed therein as the drive member is displaced in a distal direction,to allow the biocompatible wound closure material to penetrate into thebody tissue to be repaired or joined.

The staple cartridge can further include one or more laterally spacedrows of individual staple slots, the rows of staple slots extendingalong the staple cartridge, a plurality of individual surgical stapleshaving a back span and disposed, one each, within the individual stapleslots, and a plurality of staple pushers disposed one each within thestaple slots and in a position to push one of the plurality of staplesfrom the slot, wherein the drive member is adapted to displace thestaple pushers into the slots and to concomitantly expel a quantity ofthe biocompatible wound closure material about the needles and outthrough the plurality of ducts.

The biocompatible wound closure material dispensing system furtherincludes a flexible liner extending longitudinally through the staplecartridge, wherein the liner prevents the biocompatible wound closurematerial from contacting the drive member as the drive member isdisplaced distally through the staple cartridge.

The plurality of needles have a tip, a first position wherein theneedles are entirely retained within the staple cartridge and a secondposition wherein the tips of the plurality of needles project out fromthe working surface of the staple cartridge. Each of the plurality ofneedles is preferably biased to the first position.

The surgical stapler can be for performing an open gastrointestinalanastomosis operations, an endoscopic or laparoscopic gastrointestinaloperations, and an end-to-end anastomosis operations.

The biocompatible wound closure material is an adhesive made of aprotein derived, aldehyde-based adhesive material, analbumin/glutaraldehyde material, or a cyanoacrylate-based material. Thebiocompatible wound closure material can be a tissue sealant material,wherein the tissue sealant material is made of a synthetic polyethyleneglycol-based hydrogel material. The biocompatible wound closure materialcan be a hemostat.

The plurality of ducts are preferably positioned adjacent to or alignedbetween the one or more laterally spaced apart rows of staple slots.Each of the plurality of deployable needles is provided with aretracting element for withdrawing each of the plurality of deployableneedles back into the staple cartridge after a firing of the surgicalstapler.

According to a further aspect of the present disclosure, a surgicalstapler is provided and includes a first jaw adapted to receive a staplecartridge in a distal end of the first jaw, the staple cartridgecontaining a plurality of individual surgical staples, and a workingsurface with a plurality of staple slots formed therein, a second jawhaving a staple anvil in a distal end of the second jaw, such thatduring the operation of the surgical stapler the staple cartridge andthe staple anvil can be approximated relative to each other, a drivingmember for firing the surgical staples from the staple slots and againstthe approximated staple anvil, and a tissue cauterizing systemoperatively associated with the staple cartridge for enhancing one ormore properties of adjacent layers of body tissue to be repaired orjoined by the surgical stapler, the tissue cauterizing system includinga plurality of deployable needles each having a tip, the needles beingadapted and disposed in the cartridge such that their tips can beextended out of the working surface of the staple cartridge to penetrateat least a layer of the adjacent layers of body tissue and to deliverelectrosurgical energy to the body tissue during at least one of before,after and concomitant with firing of the surgical stapler.

The tissue cauterizing system includes a source of electrical energyelectrically connected to the surgical stapler via a first and a secondpower line, and wherein the plurality of deployable needles have a firstposition wherein the plurality of deployable needles are entirelyretained within the staple cartridge and a second position wherein thetip of each of the plurality of deployable needles projects from thestaple cartridge.

The first jaw includes the driving member being adapted to be slidinglyreceived within the staple cartridge, the driving member being adaptedto displace each of the plurality of deployable needles from the firstposition to the second position.

The driving member includes an energy transmission strip, wherein theenergy transmission strip is electrically connected to the first powerline and electrically interconnects each of the plurality of deployableneedles with the first power line. Each of the plurality of deployableneedles and the transmission strip are made from an electricallyconductive material. The staple anvil is electrically connected to thesecond power line.

It is envisioned that when the plurality of deployable needles is in thesecond position and the distal end of each of the plurality ofdeployable needles penetrates into tissue at the target staple site thetip of the plurality of needles do not contact the staple anvil.Preferably, each of the plurality of deployable needles is biased to thefirst position.

The tissue cauterizing system includes a plurality of springs disposed,one each, about each of the plurality of deployable needles to bias eachof the plurality of deployable needles to the first position. The sourceof electrical energy is an electrosurgical generator.

According to a further aspect of the present disclosure, a surgicalstapler including a first jaw and a second jaw having a staple anvil, ina distal end thereof is disclosed. The surgical stapler includes astaple cartridge selectively receivable in the first jaw, wherein thestaple cartridge includes one or more laterally spaced apart rows ofstaple slots formed in an upper surface thereof, a plurality of surgicalstaples disposed, one each, within the staple slots, a plurality ofstaple pushers disposed, one each, within the staple slots in a positionto push and eject each of the plurality of staples from the stapleslots, and a plurality of deployable needles disposed within the staplecartridge, each of the plurality of deployable needles having a firstposition wherein the needle is entirely retained within the staplecartridge and a second position wherein a tip portion of the needleprojects from the staple cartridge. The surgical stapler furtherincludes a driving member operatively associated with the first jaw, thedriving member being adapted to be slidingly received within the staplecartridge and to transform a linear displacement thereof into aconcomitant transverse displacement of the plurality of staple pushersand of the plurality of deployable needles. The drive member includes anenergy transmission strip extending longitudinally along the lengththereof, and a source of electrical energy electrically connected to thesurgical stapler. The source of electrical energy includes a first powerline electrically connected to the staple anvil, and a second power lineelectrically connected to the transmission strip of the drive member andelectrically communicable with each of the plurality of deployableneedles as the driving member is displaced in a distal direction throughthe staple cartridge.

Each of the plurality of deployable needles and the transmission stripare made from an electrically conductive material. Accordingly, wheneach of the plurality of deployable needles is in the second positionthe tip of each of the plurality of deployable needles penetrates intotissue at the target staple site and does not contact the staple anvil.Preferably, each of the plurality of deployable needles is biased intothe first position.

The tissue cauterizing system includes a plurality of springs disposed,one each, about each of the plurality of deployable needles to bias eachof the plurality of deployable needles into the first position.

According to another aspect of the present disclosure, a surgical staplecartridge configured and adapted to be removably received within asurgical stapler is provided and includes a working surface, one or morelaterally spaced apart rows of staple slots formed in the workingsurface, a plurality of surgical staples disposed, one each, within thestaple slots for mechanically securing adjacent layers of body tissue toone another, and a tissue property enhancing system for enhancing one ormore properties of body tissue to be repaired or joined by the surgicalstapler, the tissue property enhancing system being configured andadapted to non-mechanically enhance the repaired or joined body tissue.The tissue property enhancing system includes a wound closer materialdispensing system for dispensing an amount of surgically biocompatiblewound closure material to a target staple site during at least one ofprior to, after and concomitant with a firing of the surgical stapler toexpel a plurality of staples loaded in the staple cartridge, the tissueproperty enhancing system comprising at least one reservoir disposed inthe staple cartridge for containing the biocompatible wound closurematerial therein, a plurality of ducts formed in the staple cartridge,wherein the plurality of ducts extend from the at least one adhesivereservoir to the upper surface of the staple cartridge, and a pluralityof deployable needles each having a tip, the needles being adapted anddisposed in the cartridge and ducts such that their tips can be extendedout of the working surface of the staple cartridge and penetrate atleast a layer of the adjacent layers of body tissue and to allow thebiocompatible wound closure material to be delivered along the exteriorof the needles and to penetrate one or more layers of the body tissue.

The tissue property enhancing system is configured and adapted todeliver an amount of the biocompatible wound closure material to atleast one of the adjacent layers of body tissue to adhere the adjacentlayers of body tissue to one another. The tissue property enhancingsystem is configured and adapted to deliver an amount of biocompatiblewound closure material between the adjacent layers of body tissue toadhere the adjacent layers of body tissue to one another.

The staple cartridge preferably includes a reservoir adapted to containa quantity of the biocompatible wound closure material. Normally each ofthe plurality of deployable needles is biased into a retractedcondition.

The body tissue property enhancing system is configured and adapted todeliver an amount of electrical energy to at least one of the adjacentlayers of body tissue to cauterize the adjacent layers of body tissue toone another. The plurality of deployable needles are adapted to deliveran amount of electrical energy to at least one of the layers of bodytissue to cauterize the same. Each of the plurality of deployableneedles is biased to a retracted condition.

In a further aspect of the present disclosure, a surgical stapler isprovided and includes a handle assembly, a tubular body portionextending from the handle assembly, a staple cartridge assemblyoperatively connected to a distal end of the tubular body, the staplecartridge including a pair of annular arrays of staple receiving slots,wherein each staple receiving slot includes a surgical staple disposedtherein for mechanically securing adjacent layers of body tissue to oneanother, an anvil member operatively connected by a shaft to the distalend of the tubular body, opposite the staple cartridge assembly, and abody tissue property enhancing system configured and adapted tonon-mechanically enhance the repairing or joining of the adjacent layersof body tissue to one another along an annular staple line formed by thefiring of the surgical stapler, the body tissue property enhancingsystem including an annular array of needle receiving slots, and aplurality of deployable needles disposed, one each, in the annular arrayof needle receiving slots for delivering the body tissue enhancer.

The body tissue property reinforcing system is configured and adapted todeliver an amount of biocompatible wound closure material to theadjacent layers of body tissue to enhance the repairing or joining ofthe adjacent layers of body tissue to one another.

The biocompatible wound closure material is preferably an adhesive andthe body tissue property enhancing system is configured and adapted todeliver an amount of the adhesive into at least one of the adjacentlayers of body tissue to adhere the adjacent layers of body tissue toone another.

The surgical stapler is for performing an end-to-end anastomosisoperation.

The staple cartridge assembly includes an staple pusher including adistal portion defining concentric rings of peripherally spaced fingersadapted to be receivable, one each, within a respective one of the pairof annular arrays of staple receiving slots and a respective one of theannular array of needle receiving slots. Each deployable needle ispreferably biased into a retracted position, preferably by a spring.

The surgical stapler further includes a plurality of capsules disposed,one each, in the array of needle receiving slots, between a respectiveneedle and a respective finger which is receivable in the needlereceiving slot. Each capsule encapsulates a quantity of biocompatiblewound closure material therein. Each capsule is adapted to rupture uponapplication of a compressive force. The compressive force is applied toeach of the capsules by the distal advancement of the fingers receivablewithin the needle receiving slots and through the respective needlereceiving slots.

It is envisioned that distal advancement of the fingers receivablewithin the needle receiving slots causes the plurality of needles todeploy.

The body tissue property reinforcing system is configured and adapted todeliver an amount of electrical energy to the adjacent layers of bodytissue to cauterize the adjacent layers of body tissue to one another.The body tissue property enhancing system is preferably configured andadapted to deliver an amount of electrical energy to at least one of theadjacent layers of body tissue to cauterize the adjacent layers of bodytissue to one another. It is contemplated that distal advancement of thefingers receivable within the needle receiving slots causes theplurality of needles to deploy.

The anvil member includes a plurality of contact pads disposed, oneeach, in juxtaposed axial alignment with each of the plurality ofdeployable needles. It is envisioned that each of the plurality offingers receivable within the needle receiving slots, each of theplurality of needles and each of the contact pads are made from anelectrically conductive material. Each of the plurality of fingersreceivable within the needle receiving slots is electrically connectedto a power line adapted to deliver electrical energy to the plurality offingers receivable within the needle receiving slots.

Each of the plurality of contact pads are electrically connected to apower line adapted to at least one of deliver and dissipate electricalenergy to and/or from each of the plurality of contact pads. Each of theplurality of fingers receivable within the needle receiving slots, eachof the plurality of needles and each of the contact pads areelectrically connected to a source of electrical energy.

It is an object of the present disclosure to provide surgicalinstruments which apply surgical staples and one biocompatible woundclosure materials, for example, adhesives, sealants and hemostats and/orother enhancers, e.g., energy for cauterization, to enhance one or moreproperties of body tissue to be repaired or joined by the surgicalstaples.

It is another object of the present disclosure to provide theaforementioned surgical instruments which can be in the form of surgicalstaplers and cartridges and disposable loading units for surgicalstaplers.

It is another object of the present disclosure to provide a staplingdevice with a body tissue property enhancing system.

It is another object of the present disclosure to provide surgicalinstruments for stapling and enhancing the adhesion of the body tissuerepaired or joined by the surgical staples.

It is yet another object of the present disclosure to provide surgicalstapling instruments for reducing or preventing leakage of fluid wherebody tissue has been repaired and/or joined by staples.

It is yet another object of the present disclosure to provide surgicalstapling instruments for reducing or preventing bleeding where the bodytissue has been repaired and/or joined by the staples.

It is yet another object of the present disclosure to provide staplingdevices electrocautery capabilities for stapling and welding and/orcauterizing tissue.

It is still another object of the present disclosure to provide surgicalstaplers that can employ staples in combination with biocompatible woundclosure materials, e.g., adhesives and/or electrocautery to improve thestaple/tissue holding strength, healing patterns, sealing, hemostasisand long term patency of the staple line.

It is a further object of the present disclosure to provide surgicalstaplers having fewer staples and mechanical components therein.

It is still a further object of the present disclosure to providesurgical staplers which are less expensive to manufacture, due to thereduced number of components, which require a reduced firing force andwhich allow a reduced criticality of manufacturing tolerances of some ofthe components of the surgical staplers.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with a general description of the disclosure given aboveand the detailed description of the embodiments given below, serve toexplain the principles of the disclosure.

FIG. 1 is a perspective view of a surgical stapler in accordance withthe present disclosure;

FIG. 2 is an enlarged partial perspective view, with portions brokenaway, of a distal end of a staple cartridge of the surgical staplershown in FIG. 1;

FIG. 3 is an enlarged longitudinal vertical cross-sectional schematicview, with portions in side elevation, of the distal end of the surgicalstapler of FIG. 1 illustrating the firing thereof;

FIG. 3A is an enlarged longitudinal vertical cross-sectional schematicview, with portions in side elevation, of the distal end of a surgicalstapler, according to an alternate embodiment of the present disclosure,illustrating the firing thereof;

FIG. 4 is a perspective view of a surgical stapler in accordance with analternative embodiment of the present disclosure;

FIG. 5 is an enlarged longitudinal vertical cross-sectional schematicview, with portions is side elevation, of the distal end of the surgicalstapler of FIG. 4;

FIG. 6 is a perspective view of a removable staple cartridge inaccordance with any one of the embodiments illustrated above;

FIG. 7 is a perspective view of a surgical stapler in accordance withanother embodiment of the present disclosure;

FIG. 8 is an enlarged vertical cross-sectional view taken longitudinallythrough the cartridge assembly of the surgical stapler of FIG. 7 andillustrating a staple line reinforcing system in accordance with anembodiment of the present disclosure:

FIG. 9 is an enlarged partial sectional view taken along lines 9-9 ofFIG. 8;

FIG. 10 is an enlarged view of the area indicated as 10 in FIG. 8;

FIG. 11 is an enlarged vertical cross-sectional view takenlongitudinally through the cartridge assembly of the surgical stapler ofFIG. 7 and illustrating a staple line reinforcing system in accordancewith another embodiment of the present disclosure; and

FIG. 12 is an enlarged view of the area indicated as 12 in FIG. 11.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the presently disclosed surgical stapler willnow be described in detail with reference to the drawing figures whereinlike reference numerals identify similar or identical elements. As usedherein and as is traditional, the term “distal” refers to that portionwhich is further from the user while the term “proximal” refers to thatportion which is closer to the user.

There are several known types of surgical staplers for variousprocedures with each stapler including a staple anvil and staplecartridge which are adjustably approximated relative to each other. Atypical staple cartridge usually has at least two laterally spaced rowsof staple slots and staples therein for mechanically joining adjacentlayers of tissue to one another. The staple anvil likewise usuallyincludes two rows of staple forming depressions formed therein which arealigned with the rows of staples slots in the cartridge. In use, each ofthe surgical staplers involves gripping tissue to be fastened betweenthe staple cartridge and the staple anvil, ejecting individual staples,forcing the staples through the gripped tissue and into respectivestaple forming depressions and forming or closing the staples againstthe staple forming depressions thereby mechanically joining the adjacentlayers of tissue to one another.

While the following description will generally relate to linear-typesurgical staplers, it will be understood that the present disclosureapplies to any of several known types of surgical staplers specificallyadapted for use in various procedures, such as end-to-end anastomosis;circular end-to-end anastomosis; gastrointestinal anastomosis;endoscopic or laparoscopic gastrointestinal anastomosis and transverseanastomosis. Specific examples of staplers for these various proceduresinclude but are not limited to, for example, EEA™, CEEA™, GIA™,EndoGIA™, and TA™ each of which are available from Tyco HealthcareGroup, LP, Norwalk, Conn.

Referring now in detail to the drawings, FIGS. 1-3 show a surgicalstapler generally designated as 100 in accordance with an embodiment ofthe present disclosure. Surgical stapler 100 includes a first handle 102having a first jaw 103 configured and dimensioned to receive areplaceable staple cartridge 104 (e.g., a disposable loading unit or“DLU” as seen in FIG. 6) in a distal end thereof, and a second handle106 having a second jaw 107 defining a staple anvil 108 formed in adistal end thereof, such that staple cartridge 104 is juxtaposed andsubstantially aligned with staple anvil 108.

FIG. 2 shows that staple cartridge 104 of surgical stapler 100 includesa pair of substantially parallel spaced apart side walls 110 and 112, abottom wall 114 and a top wall 116. Preferably, top wall 116 islongitudinally divided into a pair of surface portions 118 and 120,respectively, by a knife track 122 extending therealong. Knife track 122is configured and adapted to receive slidable cutting means (not shown)therein.

As seen in FIGS. 2 and 3, each surface portion 118 and 120 includes apair of laterally spaced offset rows of staple slots 124 configured andadapted to retain a surgical staple “S” therein and extendingsubstantially along a length, preferably the entire length thereof.While a pair of rows of staple slots 124 is preferred for each surfaceportion 118, 120, it is contemplated that any number of rows (e.g., one,three, etc.) can be provided depending on the instrument and theapplication. Staple cartridge 104 further includes a plurality of staplepushers 125, in this embodiment each slidably disposed beneath a staple“S” in a staple slot 124. A plurality of staple pushers can be joinedinto or as a unitary or integral structure, such that the structure canpush or eject a plurality of staples “S” in, or from, a plurality ofstaple slots. First handle 102 of surgical stapler 100 further includesat least one drive member 127 slidingly receivable into staple cartridge104. Drive member 127 includes an angled surface 129 which transforms alinear displacement of drive member 127 into a transverse displacementof staple pushers 125. In use, as drive member 127 is advanced distally,it acts like a cam to drive staple pushers 125, and in turn to expelstaples “S” through respective staple slots 124, through tissue “T” andinto staple forming depressions 109 of staple anvil 108.

Surgical stapler 100 includes a body tissue property enhancing systemconfigured and adapted to enhance one or more properties of the bodytissue to be repaired or joined by surgical staples fired into the bodytissue. The body tissue property enhancing system can be or include astaple line surgical enhancing or reinforcing system (hereafter“reinforcing system”) for non-mechanically reinforcing the repaired orjoined tissue created by the mechanical fastening of staples “S”.According to one embodiment, surgical stapler 100 includes abiocompatible wound closure material dispensing system for dispensing anamount of a surgically biocompatible wound closure material, e.g.,adhesive, sealant or hemostat, to a target staple site either before,after and/or concomitantly with the expelling of staples “S”. In oneaspect of the disclosure, “biocompatible wound closure materialdispensing system” includes side walls 110, 112, bottom wall 114 and topwall 116 of staple cartridge 104 which define at least one adhesivereservoir 126 extending longitudinally through staple cartridge 104.Adhesive reservoir 126 is configured and adapted to retain an amount ofsurgical biocompatible wound closure material, e.g., an adhesive, “A”therein. Staple cartridge 104 further includes a plurality of channelsor ducts 128 formed along the cartridge and extending from reservoir 126to surface portions 118, 120.

Accordingly, in use, as one or more drive or driving members 127 movedistally through first jaw 103 or cartridge 104, and displace staplepushers 125 through staple slots 124, which in turn drive staples “S”through tissue “T”, drive members 127 concomitantly force biocompatiblewound closure material, e.g., adhesive, “A” from reservoir 126 throughducts 128 and into contact with tissue “T”.

It is envisioned that an enclosure or container adapted for fit andfunction could be employed in the cartridge or cartridge reservoir 126for containing the biocompatible wound closure material.

As seen in FIG. 3, it is further envisioned that an elongated flexibleliner 131 can be disposed within reservoir 126 such that as drive member127 is distally advanced through reservoir 126, liner 131 can ride upangled surface 129 of drive member 127 to thereby force biocompatiblewound closure material “A” out through ducts 128. The liner can assistin driving or camming pushers 125 up the angular camming surface ofdrive member 127.

While a single adhesive reservoir 126 defined by walls of cartridge 104or liner 131 has been shown and described in FIGS. 2 and 3, it isenvisioned that a plurality of discrete adhesive reservoirs can beemployed, for example, even one reservoir per duct 128 or set ofadjacent ducts 128. Preferably, each reservoir is defined by a chamber,preferably a flexible chamber which is configured and adapted to containor store or retain a quantity of adhesive “A” therein. In this manner,when the plurality of reservoirs (one shown) are compressed, upon distalmovement of drive members 127, a quantity of biocompatible adhesive “A”is squeezed in series out of each of the plurality of liners.

One or more liners 131 can be shaped and tailored to provide the desiredpressure at the right time to feed adhesive from the one or more linersand through the ducts. For example, an elongated and/or wide-bodiedliner for a plurality of ducts, in the longitudinal and/or transversedirection(s), can be compartmentalized to provide a series ofcompartments whose interstitial walls can break or leak upon exceeding acertain desired or selected force imparted by drive member 127. Liners131 can be of shorter height at its distal end than at its proximal endto accommodate or tend to equalize pressure or build up at the distalend of each liner as drive member 127 moves distally toward the distalend of cartridge 104. Liner 131 can be made of any suitable hermeticmaterial or combination of materials.

Surgical stapler 100 effectively joins or fastens adjoining layers oftissue “T” to one another generally in two distinct manners. In thefirst manner, surgical stapler 100 applies a series of staples “S” tothe layers of tissue “T” much like a conventional surgical stapler bydriving staples “S” through adjacent layers of tissue “T” and into anvilpockets 109 of staple anvil 108, thereby mechanically forming the legsof staples “S” against anvil pockets 109 and repairing or joining theadjacent layers or edges of tissue “T” to one another. In the secondmanner, surgical stapler 100 applies a line or lines or a series oflines or drops or beads of biocompatible wound closure material, e.g.,adhesive, “A” along a or the length of the staple array, row(s) ofline(s) by expelling a quantity of biocompatible wound closure material“A” from reservoir 126, through ducts 128, to or into the adjacenttissue or layers or edges of tissue “T”.

The rows of staples “S” provide the necessary mechanical retaining forceto hold the adjacent tissue or layers or edges of tissue “T” secured toone another during the healing process while the application ofbiocompatible wound closure material, here, adhesive “A” fills the gapsabout the legs of staples where they penetrate the tissue, and/orbetween aligned or adjacent staples “S” in or adjacent, along one ormore arrays, lines or rows of staples “S”, and provides additionalnon-mechanical enhancing properties to staples “S” and particularly tothe stapled repaired or joined tissue. In addition, for example, byproviding a line of adhesive “A”, between two adjacent rows of staples“S”, a third row of staples “S”, generally associated with conventionalsurgical staplers, sometimes depending, e.g., on the application, may beeliminated thereby reducing the number of staples to be applied, thenumber of mechanical parts of the stapler, thereby reducing the overallcost of manufacture and assembly of the surgical stapler.

While spot or non-continuous adhesive application has been primarilydisclosed, it is envisioned that a less interrupted or uninterrupted orcontinuous line or bead of biocompatible wound closure material, e.g.,adhesive, “A” can be applied along a or the entire length of one or morerows of staples “S”. If a continuous line of adhesive application isdesired, it is envisioned that ducts 128 need to be closely spaced toone another or their ports elongated so that an individual application,e.g., spot of adhesive “A” joins with an adjacent application or spot ofadhesive “A”. Alternatively, a longitudinal duct (not shown) can beformed in the working surface of the cartridge along each side of knifetrack 122 (see FIG. 2) and oriented such that adhesive “A” is expelledbetween the layers or edges of tissues “T” following a cutting of theadjacent layers of tissues “T” by cutting means (e.g., a knife).Moreover, in lieu or in addition to a single line of biocompatibleadhesive “A” per surface 118 and 120 as has been disclosed, it isenvisioned that any suitable number of lines of adhesive “A” can beprovided along respective surfaces 118 and 120.

A single series or line of ports 129 for applying adhesive “A” can beformed between adjacent rows of staples “S”. However, if multiple linesof adhesive “A” are provided as in FIG. 2, the lines can be appliedeither inside of or outside of rows of staples “S”. In addition, insurgical staplers not having a knife track 122 dividing top wall 116,the rows of staples “S” and the line(s) of adhesive “A” can alternatewith one another, such that the rows of staple “S” can be outside of thelines of adhesive “A”, or the lines of adhesive “A” can be outside ofthe rows of staples “S” or any combination thereof.

Turning now to FIG. 3A, a distal end of a surgical stapler 100,according to an alternative embodiment of the present disclosure, isshown. As seen in FIG. 3A, surgical stapler 100 includes a deployableneedle 140 operatively disposed within each duct 128′. Preferably,deployable needles 140 are configured and adapted to penetrate a layerof tissue “T” in order to deliver adhesive “A” between two adjacentlayers of tissue “T”. It is preferable that each drive member 127 isconfigured and adapted to act as a camming surface directly engaging theheads 140′ of needles 140, or for indirectly engaging them through liner131 to deploy needles 140, from ducts 128, through a first layer of bodytissue “T” such that tip 142 of each needle 140 is located substantiallybetween adjacent layers of tissue “T” and to expel a quantity ofbiocompatible adhesive “A” through each individual needle 140. Theadhesive material need not be but preferably is expelled from needles140 when tip 142 of needle 140 is activated or adjacent the adjoiningtissue surfaces.

Accordingly, in use, as drive members 127 are moved distally throughfirst jaw 103, drive members 127 sequentially transversely displacestaple pushers 125 through respective staple slots 124, which in turndrives staples.“S” through the layers of tissue “T”. Concomitantly,drive members 127 sequentially deploy and drive needles 140 from ducts128 in a manner such that tips 142 penetrate through a proximate-mostlayer of tissue “T”, preferably, a distance such that tips 142 ofneedles 140 are positioned substantially between the adjoining surfacesof the layers of tissue “T” and to concomitantly expel or force adhesive“A” out through ducts 128 and needles 140 to the region between adjacentlayers of tissue “T”. Preferably, needles 140 are positioned such thatneedles 140 expel a quantity of biocompatible adhesive “A” at a locationbetween successive staples “S” thereby filling the gaps which existbetween adjacent staples “S”. Alternatively, needle tips 142 canpenetrate through each layer of tissue such that once needles 140 arewithdrawn from tissue “T”, adhesive “A” will remain or distribute itselfin the space or hole formed by needle 140.

It is contemplated that needles 140 can be provided with withdrawingmeans operatively coupled thereto and configured and adapted to withdrawneedles 140 into ducts 128 of staple cartridge 104 after biocompatiblewound closure material, e.g., adhesive, “A” has been applied into,between or through the adjacent layers of tissue “T”. For example, inanother embodiment, drive members 127 can having a shaped, e.g.,undulating, upper surface which rises and falls along a or the lengththereof while each needle 140 can have a compression spring 144 disposedaround it and, e.g., tacked at one end to top wall 116 and at its otherend to head 140′ to bias spring 144 in a direction which causes needle140 to remain in contact with the surface of the drive member 127 in themanner of a cam follower. In this manner, needles 140 will rise and fallalong with the profile of the upper surface of drive member 127 (i.e.,deploy on distal movement and retract upon proximal movement). Thisfeature is preferable so that the stapled tissue with adhesive materialapplied thereto can be easily separated from the jaws of the stapler andpreferably also so that biocompatible adhesive “A” does not contact thesurface of the surgical stapler or cause layers of tissue “T” to adhereto the surgical stapler.

While a fully self-contained surgical stapler 100 has been describedrelative to FIGS. 1-3A, it is contemplated and within the scope of thepresent disclosure that surgical stapler 100 can be provided with afluid coupling member 150 (see FIG. 1) preferably extending from firsthandle 102, or from second handle 106 or from both handles 102 and 106.Coupling member 150 can be in fluid communication with reservoir 126 sothat surgical stapler 100 can be fluidly coupled to a source ofbiocompatible adhesive 152, via a conduit (e.g., tube) 154. Accordingly,in use, biocompatible adhesive “A” can be applied to the target surgicalsite from remote source 152.

Surgical biocompatible wound closure materials which can be employed inor applied the surgical instruments, especially surgical staplers,include adhesives whose function is to attach or hold organs, tissues orstructures, sealants to prevent fluid leakage, and hemostats to halt orprevent bleeding. Examples of adhesives which can be employed includeprotein derived, aldehyde-based adhesive materials, for example, thecommercially available albumin/glutaraldehyde materials sold under thetrade designation BioGlue™ by Cryolife, Inc., and cyanoacrylate-basedmaterials sold under the trade designations Indermil™ and Derma Bond™ byTyco Healthcare Group, LP and Ethicon Endosurgery, Inc., respectively.Examples of sealants which can be employed include fibrin sealants andcollagen-based and synthetic polymer-based tissue sealants. Examples ofcommercially available sealants are synthetic polyethylene glycol-based,hydrogel materials sold under the trade designation CoSeal™ by CohesionTechnologies and Baxter International, Inc. Examples of hemostatmaterials which can be employed include fibrin-based, collagen-based,oxidized regenerated cellulose-based and gelatin-based topicalhemostats. Examples of commercially available hemostat materials arefibrinogen-thrombin combination materials under sold the tradedesignations CoStasis™ by Tyco Healthcare Group, LP and Tisseel™ sold byBaxter International, Inc.

The biocompatible wound closure materials which can be employed with thesurgical instruments, e.g., staplers disclosed herein preferably arenon-toxic, capable of adhering to biological tissue, reaching stabilityquickly (e.g., typically within about 30 seconds to about 5 minutes),setting in wet conditions, and bonding to both biological tissue andsynthetic materials, and provide sufficient strength to furtherstabilize the staple line. Biocompatible adhesives made up ofproteinaceous materials and cross-linking agents have thesecharacteristics. Biocompatible adhesives containing protein and across-linking agent are disclosed in U.S. Pat. No. 5,385,606 to Kowanko,the entire disclosure of which is incorporated herein by reference.

While the above described embodiments relate generally to an open-typelinear surgical stapler, endoscopic and laparoscopic linear typestapling instruments are also within the scope of the presentdisclosure. A typical endoscopic stapling apparatus includes a handle,an operative tool (i.e., an end effector) and an elongated shaft forinterconnecting the operative tool to the handle. In general, theoperative tool is designed to approximate and then to staple and dividetissue held therebetween. It is contemplated that the operative tool isa pair of opposed jaws including a staple anvil and a staple cartridgecouplable, e.g., pivotally or transversely, to one another. Referencecan be made to commonly assigned U.S. Pat. Nos. 6,330,965 and 6,241,139to Milliman et al., the entire contents of which are incorporated hereinby reference, for a more detailed explanation of the operation ofsurgical stapling apparatus 300 and of the approximation of the staplecartridge with the staple anvil.

In FIGS. 4 and 5, an alternative embodiment of a surgical stapler inaccordance with the invention is shown generally as 200. Surgicalstapler 200 includes a first handle 202 having a first jaw 203configured and dimensioned to receive a staple cartridge 204 in a distalend thereof, and a second handle 206 having a second jaw 207 defining astaple anvil 208 formed in a distal end thereof, such that staplecartridge 204 is juxtaposed and substantially aligned with staple anvil208.

Staple cartridge 204 of surgical stapler 200 includes a tissue propertyenhancing system for enhancing one or more properties of body tissue tobe repaired or joined by a surgical stapler, the system being adapted tonon-mechanically enhance the repaired or joined tissue. According to oneembodiment, surgical stapler 200 includes a tissue cauterizing systemfor joining adjacent layers of body tissue to one another in anon-mechanical fashion during at least one of before, after orconcomitant with a firing of surgical stapler 200 and to expel surgicalstaples “S” from staple cartridge 204. The tissue cauterizing systemincludes a source of electrical energy 256 (e.g., an electrosurgicalgenerator) electrically connected to surgical stapler 200 via powerlines 250, 252, and needles 240 operatively disposed within each duct228 of staple cartridge 204. Preferably, first power line 250 extendsproximally from first handle 202 and is in electrical contact with andprovides a source of electrical energy and/or power to deployableneedles 240 of staple cartridge 204.

Preferably, power line 250 is in electrical contact with first handle202 and, more preferably, power line 250 is in electrical contact withan energy transmission strip 260 provided along an upper surface ofdrive member 227. Preferably, power line 252 is in electrical contactwith second handle 206 and, more preferably, power line 252 is inelectrical contact with anvil 208.

According to an embodiment of the present disclosure, first jaw 203,drive member 227 and staple pushers 225 are formed of a non-conductiveor insulative material while needles 240 and transmission strip areformed of a conductive material. It is envisioned that anvil 208 ofsecond jaw 207 is formed from a conductive material. Alternatively,anvil 208 can be formed of non-conductive or insulative material havingareas or contact pads (not shown) disposed on the surface thereof whichcontact pads are formed from a conductive material. Preferably, acontact pad is in juxtaposition with a respective needle 240.Alternatively, if anvil 208 is made entirely of a conductive material,each anvil pocket 209 can be lined with a non-conductive or insulativematerial.

In use, first jaw 203 and second jaw 207 are positioned on either sideof the surgical site where adjacent layers of tissue “T” are to befastened to one another and cut in a manner such that staple cartridge204 and staple anvil 208 are in juxtaposition. Surgical stapler 200 isthen fired by moving drive member 227 distally, thereby driving staplepushers 225 into staples “S”. This expels the legs of staples “S”through the adjacent layers of tissue “T” and against respective anvildepressions or pockets 209, thereby fully forming the staples andjoining the layers of tissue “T” to one another.

Concomitantly with the expelling of staples “S” from staple cartridge204, drive member 227 urges the ends of needles 240 through and beyondslots 228 into the adjacent layer(s) of tissue “T”. Preferably, the tipof each needle 240 is blunt in order to inhibit the penetration ofneedle 240 fully through the adjacent layers of tissue “T” into contactwith the surface of anvil 208. Preferably, each needle 240 is springbiased, by, for example, use of a compression spring 244 disposed aboutneedles 240 and, for example, adhesively or otherwise secured at one endto wall 216 and at the other end to the head of needle 240. Springs 244bring needles 240 into and maintain needles 240 in contact with strip260 of drive member 227.

With the layers of adjacent tissue “T” held between first jaw 203 andsecond jaw 207 and needles 240 pressing into tissue “T”, a user appliesan RF energy to needles 240 from the source of energy 256. Inparticular, the RF energy travels from the source of energy 256, throughpower line 250, strip 260, needles 240, the adjacent layers of tissue“T”, anvil 208 and out through power line 252. The RF energy is appliedfor a time and at a level sufficient to cauterize (i.e., spot weld) theadjacent layers of tissue “T” to one another.

After surgical stapler 200 has been fired, preferably drive member 227is moved in a proximal direction, such that as the distal end of drivemember 227 clears needles 240, and they are biasedly withdrawn back intostaple cartridge 204 from the expression of springs 244. Alternatively,if drive member 227 cannot be moved in a proximal direction after thefiring of staples, needles 240 can be removed from tissue “T” bydisassociating first handle 202 from second handle 206.

Surgical stapler 200 effectively joins and/or fastens adjacent layers oftissue “T” to one another in two distinct manners. In the first manner,surgical stapler 200 conventionally applies a series of staples “S” tothe adjacent layers of tissue “T” by driving staples “S” through theadjacent layers of tissue “T” and into anvil pockets 209 of staple anvil208, thereby mechanically forming the legs of staples “S” against anvilpockets 209 and joining the adjacent layers of tissue “T” to oneanother. In the second manner, surgical stapler 200 forms a series ofspot or line welds along a or the length of the staple line(s) bycauterizing the adjacent layers of tissue “T” to one another.Preferably, needles 240 are positioned such that needles 240 produce aspot weld at a location between or adjacent successive or adjacentstaples “S” thereby filling gaps which exist between adjacent staples“S”.

As seen in FIG. 6, surgical staplers 100, 200 can be provided with aremovable surgical staple cartridge 104, 204, respectively, as shown inthe form of a Disposable Loading Unit (hereinafter “DLU”). Preferably,the DLU can be configured and adapted to include the individual featuresof the tissue property enhancing systems disclosed herein or anycombinations thereof. In this manner, a single surgical stapler 100 or200 can be employed and reused while the DLU can be used and disposed ofafter each use and/or replaced with an unused DLU as needed during thesurgical procedure. For example, DLU's, with or without a knife, havingdifferent numbers of rows of staples, varying length staples, varyinglength needles and different types of biocompatible wound closurematerials can be employed. It is within the scope of this invention thatthe features of the staple cartridge 104, 204 are contemplated for DLU'sfor endoscopic and laparoscopic staplers, including endoscopicgastrointestinal and transverse anastomotic staplers.

The row of staples “S” provides the necessary retaining force to holdthe adjacent layers of tissue “T” secured to one another during thehealing process while the spot welds or lines fill the gaps betweenadjacent staples “S” in a particular row of staples “S”. In addition, incertain applications, by providing a linear succession of spot or linewelds between or adjacent the two rows of staples “S”, a third row ofstaples generally associated with conventional surgical staplers can beeliminated, thereby reducing the number of mechanical parts and reducingthe overall cost of manufacturing and assembling of the surgicalstapler.

While the above described surgical staplers have been described inconnection with a linear-type staplers, it is envisioned that the abovedisclosure can be used in connection with various other surgicalstaplers as disclosed above, such as, for example, circular-typestaplers.

Thus, FIGS. 7-10 show an alternative embodiment in the form of anannular or circular-type surgical stapler, shown generally as 300.Surgical stapler 300 includes a handle assembly 312 having at least onepivotable actuating handle member 314, and further includes an advancingmember 316. Extending from handle assembly 312, there is provided atubular body portion 320 which may be constructed so as to have a curvedshaped along its length. Tubular body portion 320 may also be straightand in other embodiments may be flexible to bend to any configuration.Body portion 320 terminates in a staple cartridge assembly 322 which isassociated with a pair of annular arrays of staple receiving slots 336including a staple 324 (see FIG. 8) disposed in each one of the staplereceiving slots 336. Positioned opposite staple cartridge assembly 322there is provided an anvil member 326 which is connected to a distal endportion of surgical stapler 300 by a shaft 328.

As seen in FIG. 8, staple cartridge assembly 322 fits concentricallywithin the distal end of tubular body portion 320. Staple cartridgeassembly 322 includes a staple pusher 330 including a proximal portion332 having a generally frusto-conical shape and a distal portiondefining two concentric rings of peripherally spaced fingers 334, eachone of which is received within a staple receiving slot 336. In oneembodiment, it is envisioned that proximal portion 332 of staple pusher330 is configured and adapted to be contacted by a distal end of adriver tube 338. Hence, upon advancing staple pusher 330 by advancingdriver tube 338, fingers 334 will pass further into staple receivingslots 336 thereby pushing staples 324 contained therein axially outward.

As seen in FIG. 8, a knife 340 substantially in the form of an open cupwith the rim thereof defining a knife edge 342 received within staplecartridge assembly 322 and mounted to a distal surface of staple pusher330. Preferably, knife edge 342 is disposed radially inward of the pairof annular arrays of staples 324. Accordingly, as staple pusher 330 isadvanced by advancing driver tube 338, knife 340 is also advancedaxially outward.

In operation, surgical stapler 300 is positioned within a tubular organin the body of the patient and the ends of the organ to be joined arepositioned in a gap between staple cartridge assembly 322 and anvilmember 326. As is conventional, the ends of the organ may be securedover anvil member 326 and staple cartridge assembly 322 by a pursestring suture prior to approximation of anvil member 326 to staplecartridge assembly 322. In order to approximate anvil member 326 towardsstaple cartridge assembly 322, grip member 318 is rotated to draw anvilmember 326 toward staple cartridge assembly 322 and into positionagainst staple cartridge assembly 322. Once the proper distance is setbetween anvil member 326 and staple cartridge assembly 322, actuatinghandles 314 may be pivoted to drive staple pusher 330, and in turnstaples 324 and annular knife 340, through the tissue and against anvilmember 326 to thereby complete the anastomosis.

With continued reference to FIG. 8, staple cartridge assembly 322includes a body tissue property enhancing system including at least oneannular array, preferably two annular arrays, of deployable needles 350positioned within needle receiving slots 352 formed in a distal end ofstaple cartridge assembly 322. Preferably, a needle 350 is disposed ineach needle receiving slot 352. Preferably, each needle 350 is biased toa retracted position within its respective needle receiving slot 352 bya spring 354 positioned about each needle 350 and disposed between aninner distal surface 322 a of staple cartridge assembly 322 and a flange350 a formed at the proximal end of each needle 350.

A quantity of biocompatible wound closure material is provided withineach needle receiving slot 352, preferably at a location proximal ofneedle 350. Preferably, a plurality of rigid, semi-rigid or flexiblecontainers, here preferably shown as semi-rigid or flexible capsules356, containing biocompatible wound closure material can be provided,one each, within needle receiving slots 352, wherein each capsule 356encapsulates and/or includes a quantity of biocompatible wound closurematerial retained therein. It is envisioned that the distal portion ofstaple pusher 330 further defines an additional ring of peripherallyspaced fingers 358, each one of which is received within a respectiveneedle receiving slot 352.

In operation, upon advancing staple pusher 330, by advancing driver tube338, fingers 358 will pass distally further into needle receiving slots352 thereby pushing biocompatible wound closure material containingcapsules 356 against the proximal end of needles 350 resulting in thedeployment of needles 350 out of needle receiving slots 352. As seen inFIG. 10, needles 350 preferably penetrate at least one layer preferablyboth layers of tissue “T” clamped between staple cartridge assembly 322and an anvil surface 326 a of anvil member 326. Once needles 350 arefully deployed, as staple pusher 330 is advanced further, thecompressive forces exerted on capsules 356 cause capsules 356 to rupturethereby dispensing biocompatible wound closure material into needlereceiving slot 352. With capsules 356 ruptured, continued distaladvancement of staple pusher 330 results in the expulsion ofbiocompatible wound closure material out through and/or about needles350.

In this manner, the annular arrays of staples 324 provide the necessaryretaining force to mechanically hold the adjacent layers of tissue “T”secured to one another during the healing process while a suitablebiocompatible wound closure material fills the gaps between adjacentstaples 324 in a particular annular array of staples 324.

Turning now to FIGS. 11 and 12, in another embodiment, staple cartridgeassembly 320 includes a tissue property enhancement system including atleast one annular array, preferably two annular arrays, of deployableneedles 350′ positioned within a corresponding needle receiving slot352′ formed in a distal end of staple cartridge assembly 322.Preferably, each needle 350′ is biased to a retracted position withinits respective needle receiving slot 352′. More preferably, each needle350′ is biased to the retracted position by a plurality of springs 354′positioned, one each, about needles 350′ and disposed between an innerdistal surface 322 a of staple cartridge assembly 322 and a flange 350a′ formed at the proximal end of each needle 350′. Preferably, needles350′ are made from an electrically conductive material.

The distal portion of staple pusher 330 further defines an additionalring of peripherally spaced fingers 358′, each one of which is receivedwithin a respective needle receiving slot 352′. Preferably, fingers 358′are also made from an electrically conductive material. In this manner,when fingers 358′ are in contact with needles 350′, electrical energycan be transmitted from fingers 358′ to needles 350′. It is envisionedthat a proximal end of each finger 358′ is in electrical contact with atleast one power line 360′ which extends through surgical stapler 300 andpreferably to a source of electrical energy as described above.

In operation, upon advancing staple pusher 330, by advancing driver tube338, fingers 358′ will pass further into needle receiving slots 352′ andin turn against the proximal end of needles 350′ resulting in thedeployment of needles 350′ out of needle receiving slots 352′. As seenin FIG. 12, needles 350′ preferably penetrate one layer of tissue “T”which is clamped between staple cartridge assembly 322 and an anvilsurface 326 a of anvil member 326. Once needles 350′ are fully deployed,a suitable amount of electrical energy can be transmitted to needles350′ through power lines 360′ and fingers 358′ to cauterize and/or fuseadjacent layers of tissue “T” to one another. Preferably, as seen inFIG. 12, anvil surface 326 a is provided with a plurality of electricalcontact pads 362′ positioned, one each, in juxtaposed axial alignmentwith needles 350′. Preferably, each contact pad 362′ is in electricalcontact with the source of electrical energy via at least one power line364′ extending from each contact pad 362′, through anvil member 326,through shaft 328 and on to the source of electrical energy (i.e.,source of electrical energy 256 from FIG. 4).

In this manner, the annular arrays of staples 324 provide the necessaryretaining force to mechanically hold the adjacent layers of tissue “T”secured to one another during the healing process and the spot weldsfill the gaps between adjacent staples 324 in a particular row ofstaples 324 and thereby enhance the holding force. In addition, byproviding a succession of spot welds between the adjacent rows ofstaples 324, a third row of staples generally associated withconventional surgical staplers can be eliminated thereby reducing thenumber of mechanical parts and reducing the overall cost ofmanufacturing and assembly of the surgical stapler.

It will be understood that various modifications may be made to theembodiments of the presently disclosed surgical stapler. Therefore, theabove description should not be construed as limiting, but merely asexemplifications of preferred embodiments. Those skilled in the art willenvision other modifications within the scope and spirit of the presentdisclosure.

1. A surgical stapler comprising: a first jaw having a staple cartridgecontaining a plurality of surgical staples, and having a working surfacewith a plurality of staple slots formed therein; a second jaw having astaple anvil, such that during the operation of the surgical stapler thestaple cartridge and the staple anvil can be approximated relative toone another; a driving member for firing the surgical staples from theirstaple slots and against the staple anvil; the staple cartridge having aliner, the liner defining a reservoir in communication with a pluralityof ducts formed in the working surface of the staple cartridge, theliner having a first position in which the reservoir has a first volume,and a second position in which the reservoir has a second volume, thesecond volume being less than the first; and a quantity of biocompatiblewound closure material disposed in the reservoir and the quantity ofbiocompatible wound closure material being selected so that the woundclosure material is forced from the reservoir through the ducts as theliner moves from the first position to the second position.
 2. Thesurgical stapler according to claim 1, further comprising a plurality ofneedles, one of the plurality of needles being disposed in each one ofthe ducts.
 3. The surgical stapler according to claim 2, wherein theplurality of needles have a first position wherein the needles areentirely retained within the staple cartridge and a second positionwherein the plurality of needles project out from the working surface ofthe staple cartridge.
 4. The surgical stapler according to claim 1,wherein: the staple slots are arranged in one or more laterally spacedrows, the rows of staple slots extending along the staple cartridge; oneof the plurality of surgical staples being disposed within each one ofthe staple slots; and a plurality of staple pushers, one of the staplepushers being disposed in each one of the staple slots and in a positionto push the corresponding one of the plurality of staples from the slot.5. The surgical stapler according to claim 1, wherein the liner isdisposed between the working surface of the staple cartridge and thedriving member to prevent the biocompatible wound closure material fromcontacting the driving member as the driving member is displaceddistally through the staple cartridge.
 6. The surgical stapler accordingto claim 1, wherein the biocompatible wound closure material is anadhesive comprised of a protein derived, aldehyde-based adhesivematerial.
 7. The surgical stapler according to claim 6, wherein thebiocompatible wound closure material is an adhesive comprised of analbumin/glutaraldehyde material.
 8. The surgical stapler according toclaim 6, wherein the biocompatible wound closure material is an adhesivecomprised of a cyanoacrylate-based material.
 9. The surgical stapleraccording to claim 1, wherein the biocompatible wound closure materialis a tissue sealant material.
 10. The surgical stapler of claim 1,wherein the tissue sealant material is comprised of a syntheticpolyethylene glycol-based hydrogel material.
 11. The surgical stapleraccording to claim 1, wherein the biocompatible wound closure materialis a hemostat.
 12. A surgical stapler comprising: a first jaw having astaple cartridge having a longitudinally extending working surface witha plurality of staple slots formed therein, the staple slots beingarranged in a plurality of longitudinally extending rows, each stapleslot containing one of a plurality of surgical staples and one of aplurality of staple pushers disposed in each slot so as to push thecorresponding staple from the slot; a second jaw having a staple anvil,such that during the operation of the surgical stapler the staplecartridge and the staple anvil can be approximated relative to oneanother; a driving member for moving longitudinally to drive thesurgical staples from their staple slots and against the staple anvil;the staple cartridge having a longitudinally extending liner, the linerdefining a reservoir in communication with a plurality of ducts formedin the working surface of the staple cartridge, the liner being disposedadjacent the driving member, the driving member compressing thereservoir as it moves longitudinally; and a quantity of biocompatiblewound closure material disposed in the reservoir and the quantity ofbiocompatible wound closure material being selected so that the woundclosure material is forced from the reservoir through the ducts as thedriving member moves longitudinally.
 13. The surgical stapler accordingto claim 12, further comprising a plurality of needles, one of theplurality of needles being disposed in each one of the ducts.
 14. Thesurgical stapler according to claim 13, wherein the plurality of needleshave a first position wherein the needles are entirely retained withinthe staple cartridge and a second position wherein the plurality ofneedles project out from the working surface of the staple cartridge.15. The surgical stapler according to claim 12, wherein the liner isdisposed between the working surface of the staple cartridge and thedriving member to prevent the biocompatible wound closure material fromcontacting the driving member as the driving member is displaceddistally through the staple cartridge.
 16. The surgical stapleraccording to claim 12, wherein the biocompatible wound closure materialis an adhesive comprised of a protein derived, aldehyde-based adhesivematerial.
 17. The surgical stapler according to claim 16, wherein thebiocompatible wound closure material is an adhesive comprised of analbumin/glutaraldehyde material.
 18. The surgical stapler according toclaim 16, wherein the biocompatible wound closure material is anadhesive comprised of a cyanoacrylate-based material.
 19. The surgicalstapler according to claim 12, wherein the biocompatible wound closurematerial is a tissue sealant material.
 20. The surgical stapler of claim12, wherein the tissue sealant material is comprised of a syntheticpolyethylene glycol-based hydrogel material.
 21. The surgical stapleraccording to claim 12, wherein the biocompatible wound closure materialis a hemostat.